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Transcript
SCCP
Student Clinical Digest
Clinical Pharmacist
Presented by the Student College of Clinical Pharmacy, the University of Georgia
College of Pharmacy student chapter of the American College of Clinical Pharmacy
Volume 1 Issue 2
Winter 2013
Clinical Spotlight
Schedule Changes
Antibiotic M isuse
Ambulatory Care
Residency Q&A
with Dr. Beth
Bryles Phillips
Find out what
changes are ahead
for hydrocodone
dispensing
Test your
antibiotic
knowledge!
Page 1
Page 2
Page 3
Spotlight:
Ambulatory Care
Anh Nguyen,
Marisa Fortunato,
Pharm.D. Candidates
University of Georgia
Drug
Shortages
Discover
ZKDW¶VFDXVLQJ
this ongoing
problem
Page 4
BP: I decided that I wanted to
pursue a specialized training in
ambulatory care when I was in my
PGY-1 residency year. I was very
excited about all areas of pharmacy
such as critical care, cardiology,
etc. But I found that I loved
ambulatory care the most because I
really enjoyed interacting and
developing close relationships with
my patients as well as being able to
evaluate the long-term impacts of
their drug therapies.
students and residents the patients
who we are going to see that day.
Students then present patient cases
and we talk about important things;
after our discussion, we go see our
patients. Then we spend our
afternoon
documenting
our
recommendations in patient charts
as well as discussing relevant
clinical topics. After that, we go
EDFN WR SDWLHQWV¶ URRP ZKHUH
students get to counsel on drug
therapies.
I am very interested in academia
because I really enjoy teaching and
sharing my knowledge with
students and residents. In addition,
the publication requirement that
comes with being a faculty member
also helps me stay on top of the
game in terms of clinical
knowledge.
SCCP: What educational steps
did you take to get where you are
today?
PGY2 Residency Director
Beth Bryles Philips,
Pharm.D, BCPS
SCCP: How would you describe
your typical workday at your
practice site?
SCCP: Why did you choose a
career in academic and clinical
pharmacy with a specialty in
ambulatory care?
BP: At my practice site, I often
have my residents and APPE/IPPE
students with me. When I get there
in the morning, I discuss with my
BP: After finishing my Pharm.D.
education, I completed two years of
residency trainings : PGY-1
pharmacy practice residency at an
academic teaching hospital and
PGY-2 in Ambulatory Care at a
VA hospital. In addition, when I
was a resident, I was able to gain
opportunities
in
publication,
scholarship, research, and teaching.
Continued on page 5
1
SCCP
New Drug Digest:
Canagliflozin (Invokana) Canagliflozin is a new oral anti-diabetic agent used concurrently
Jennifer Dean,
Pharm.D. Candidate
with diet and exercise to treat type II diabetes. Being the first
sodium-glucose co-transporter 2 (SLGT2) inhibitor, canagliflozin
decreases blood glucose by causing an increase in the amount of
sugar excreted through the urine. Urinary tract infections are the
most common side effect. Important to note is that Canagliflozin is
contraindicated in patients with severe renal impairment (GFR <
30ml/min) or end stage renal disease.
Reference: Canagliflozin. Lexi-Drugs Online [ Internet] . Hudson (OH) : Lexi-Comp, Inc. 1978-2013
[ cited 2013 Nov 21] . Available from:
http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/4230722.
Approved April 2013
Janssen Pharmaceuticals
Proposed Changes to
Hydrocodone
Scheduling
Huldah Abaidoo, Pharm.D.
Candidate
Prescription drug abuse and
misuse, especially in the case of
prescription
painkillers,
has
become a growing problem in
America. It is said that 80% of the
ZRUOG¶V SDLQ SLOOV DUH FRQVXPHG LQ
WKH8QLWHG6WDWHVDQG³DOPRVWWZLFH
as many people abuse prescription
drugs as the number of people
abusing
cocaine
heroin,
hallucinogens
and
inhalants
combiQHG´ ³)'$ $LPV WR
7LJKWHQ´ )RRG DQG 'UXJ
Administration (FDA) has been
looking at various ways to respond
to this looming crisis.
One such effort is a proposal to
change
the
scheduling
of
hydrocodone combination pill,
which combine hydrocodone with
less
potent
painkillers
like
acetaminophen (e.g. Lortab or
Vicodin). Accessibility and over
prescribing by doctors, who
perceive them to be less addictive
than Schedule II medications like
Percocet, have been the main
VRXUFH RI SUREOHPV ³)'$ $Lms
WR 7LJKWHQ´ 7KH )'$ KDV
thus developed a proposal to make
scheduling of these painkillers
more restrictive by changing the
hydrocodone combination products
from a Schedule III to Schedule II
classification.
Dispensing
of
Schedule II drugs are especially
stringent because no refills of the
prescriptions
are
allowed.
Additionally,
the
prescription
would be required as a hard-copy
and verbal order prescriptions
would not be allowed.
This change has its supporters,
including the National Institute on
Drug Abuse, but it also has its
critics. It may surprise some that
many pharmacists, including the
American Pharmacists Association,
are opposed to the reschedule. This
WKH\DUJXHLV³Eecause there is clear
evidence that this change will
reduce
patient
access
to
medications and cause harm ±
largely to patients living with
FKURQLFSDLQ´³)'$5HFRPPHQGV
5HVFKHGXOLQJ´
7KH
proposal, which is still being
developed, is to be submitted to the
Department of Health and Human
Services by early December. The
Drug Enforcement Administration
(DEA) will ultimately make the
decision
about
this
change
(Statement
of
Proposed
Hydrocodone
Reclassification,
2013). With this potential change
affecting not only the patients and
doctors but also the pharmacy, it
will be interesting to see the
outcome, and more important what
else can be done to reduce the
growing epidemic of prescription
drug abuse.
References:
"FDA
Recommends
Rescheduling
Hydrocodone to Schedule II." American
Pharmacists
Association. N.p., 25
Oct.2013. <http://www.pharmacist.com/fdarecommends-rescheduling-hydrocodoneschedule-ii>. Staff, CNN, Leslie Bentz, Jacque Wilson,
Nadia Kounang, and Stephanie Smith. "FDA
Aims
to
Tighten
Control
of
Hydrocodone." CNN. Cable News Network,
25Oct.2013.
<http://www.cnn.com/2013/10/25/us/fdapainkiller-controls/>. Statement on Proposed Hydrocodone
Reclassification from Janet Woodcock,
M.D., Director,
Center
for
Drug
Evaluation and Research. U.S. Food and
Drug
Administration,
24Oct.2013.
<http://www.fda.gov/drugs/drugsafety/ucm3
72089.htm>
2
SCCP
Antibiotic Misuse: The Terrible Creation
of Superbugs
Brittany Thompson, Pharm.D. Candidate
The advances made in antibiotic treatments made since
the introduction of penicillin in the 1940s have been
vastly beneficial for patients. However, taking antibiotics
when unwarranted (such as in viral infections) or not
taking the entire course of the antibiotic contributes to the
formation of multidrug-resistant superbugs. Additionally,
the failure of first-line antibiotics means that patients must
resort to less conventional medications, many of which
are more costly and associated with more-serious side
effects.
Take this short quiz to see what you know about
antibiotic use.
What health issue does the bacteria Clostridium
difficile cause?
a. syphilis
b. throat inflammation
c. bacterial vaginosis
d. painful diarrhea
Answer: d. painful diarrhea. This bacterial infection
occurs mostly in nursing home patients and recently
hospitalized individuals. Between 2000 and 2007, the
number of deaths related to C. difficile increased 400%
because a stronger strain of the bacteria emerged in 2000.
90% of these deaths occur in people aged 65 and older. C.
difficile LVLQWKHKLJKHVWFDWHJRU\RIWKH &'&¶VEDFWHULDO
threats list.
True or False? M ost of the antibiotics sold in the
8QLWHG6WDWHVDUHXVHGLQFKLOGUHQ¶VKRVSLWDOV
Answer: False. There is evidence that more antibiotics are
used in food production than in humans. Antibiotics are
commonly used in livestock to prevent, control, and treat
disease and to promote growth, a practice that the CDC is
taking measures to halt. This is an issue because people
consuming said contaminated animal products can
develop antibiotic-resistant infections.
:KLFKFODVVRIGUXJVDUHXVHGDVD³ODVWUHVRUW´
treatment for gram-negative bacterial infections due
to concerns of nephrotoxicity and neurotoxicity?
a. Fluoroquinolones
EČ•-lactams
c. Polymyxins
d. Aminoglycosides
Polymixin B causes nephrotoxicity by increasing
membrane permeability, leading to an increased influx of
cations, anions, and water, causing cells to swell and lyse.
However, it should be noted that the dosages of
polymyxins used in former studies were considerably
higher compared to the recommended dosages
administered nowadays.
Although bacterial drug resistance is a natural event, it is
accelerated by overuse or underuse of antibiotics. In fact,
according to a recent CDC report, 2 million people in the
U.S. get infections that are resistant to antibiotics and
23,000 die as a result every year. In order to raise
awareness and combat this issue, the CDC promotes its
DQQXDOµ*HW6PDUW$ERXW$QWLELRWLFV:HHN¶LQ1RYHPEHU
to raise awareness about the threat of antibiotic resistance
with hopes of decreasing inappropriate antibiotic use.
Doctors, pharmacists and other healthcare professionals
DUH EHLQJ FDOOHG WR SUDFWLFH ³DQWLELRWLF VWHZDUGVKLS´ E\
providing antibiotics only when absolutely necessary.
References: http://www.cdc.gov/drugresistance/threat-report2013/index.html,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1550802/
Clinical Pharmacy Across the Seas
Payal Kakadiya, Pharm.D. Candidate
The American College of Clinical Pharmacy is working
with pharmacists around the globe in implementing and
DGYDQFLQJ FOLQLFDO SKDUPDF\ ³%HLQJ D &OLQLFDO
3KDUPDFLVW´ZDVILUVWRIIHUHGDWWKHth Asian Conference
on Clinical Pharmacy in Haiphong, Vietnam in September
2013. The goal of the program was to introduce the
attendees to advanced clinically pharmacy practice and
develop specific skills that pharmacists can use in their
daily practice to optimize patient care. During the threeday conference, participants discussed current issues
facing the profession, research findings, and how to
advance the education of clinical pharmacy. The sessions
provided an overview of the different patient-care
services and described the roles and responsibilities of
clinical pharmacists in different healthcare settings. Other
sessions also provided illustrative patient cases to apply
clinical knowledge and skills in real-life settings.
In June 2013, the Board of Directors of the Accreditation
Council for Pharmacy Education approved the first
international pharmacy degree program certification. This
certification attests that the program meets the
requirements set by the International Quality Criteria for
Certification of Professional Degree Programs in
Pharmacy. The first certification was given to King Saud
University College of Pharmacy in Saudi Arabia.
Answer: c. Polymixins. The toxicity of polymyxins may
be partly due to their D-amino acid and fatty acid content.
3
SCCP
Drug Shortages: History, Statistics, and
Pharmacists
Aros Mahmud, Pharm.D. Candidate
The FDA on October 31, 2013 released the Drug Shortage
Strategic Plan, outlining further strategies the agency will
implement to enhance an effort they began in 2011 ±
trying to prevent drug shortages as much as possible.
Their first efforts may have begun in 2011, but the
problem was underway for much of the years preceding
2011. Beginning in 2006, drug shortages started on a
mission.1 Whereas previously the frequency was
consistent from year to year, each year after 2006 the
number of new drugs added to the shortage list was
greater than the number added to the list during the
previous year.
President Obama finally broke the silence in 2011 and
issued an executive order, calling the FDA to action. Ever
since, manufacturers are required to warn the FDA ahead
of time when they have reason to suspect that their
product may experience shortage in the coming days or
months.2 This allows the FDA time to work with the
manufacturer and steer away the potential shortage. In
addition to the advance notice system, other steps were
also taken. As a result, in 2012, drug shortages became
half as frequent as during 2011 and the upward trend was
finally broken.3 The strategic plan of 2013 now hopes to
take that outcome and begin with it a trend in the opposite
direction.
Hospital is the setting most affected by drug shortages
because shortages tend to occur to sterile injectable
medications, as they do in 74% of incidences.1,4
Moreover, classes suffering the most shortages are
oncology drugs, antibiotics, and IV nutrients and
electrolytes.
New Drug Digest:
Macitentan (Opsumit)
Jennifer Dean, Pharm.D.
Candidate
To minimize the impact of drug shortages on patients in
this setting, the need for interdisciplinary teamwork is
heightened (YHU\RQH¶V FRPPXQLFDWLRQ OLQHV PXVW EH
FRQQHFWHG WR HYHU\RQH HOVH¶V FRPPXQLFDWLRQ OLQHV ,Q
particular, the value that the pharmacist brings is critical.
The pharmacist is able to use his/her skills, resources, and
extensive knowledge of drugs to identify the best
alternative possible when a drug runs low. When a
therapeutically equivalent substitute is not possible, the
pharmacist can provide insight on a bioequivalent
substitute or on an off-label use. Moreover, these tasks
must be performed while balancing cost consciousness. It
can be a complex decision process. At the same time,
their work allows patients to remain treated on a carefully
selected substitute. Hopefully, more patients will avoid
complications altogether when the FDA implements its
new strategies.
References:
1.
2.
3.
4.
)RRGDQG'UXJ$GPLQLVWUDWLRQ$UHYLHZRI)'$¶V
approach to medical product shortages.
http://www.fda.gov/AboutFDA/ReportsManualsForms/Repor
ts/ucm277745.htm. (accessed November 21, 2013).
The White House. 2011. Executive Order 13588.
http://www.whitehouse.gov/the-pressoffice/2011/10/31/executive-order-reducing-prescriptiondrug-shortages. (accessed November 21, 2013).
Food and Drug Administration. 2013. FDA takes two
important actions on drug shortages.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnounce
ments/ucm373044.htm. (accessed November 21, 2013).
Duke, Melissa. 2011. Mitigating the impact of medication
shortages on public health.
http://japha.org/article.aspx?articleid=1043982. (accessed
November 21, 2013).
Macitentan is the first and only treatment for pulmonary arterial
hypertension that prevents disease progression. It prevents
vasoconstriction in the pulmonary artery by inhibiting the binding
of endothelin-1, a potent vasoconstrictor, to endothelin receptors
ETA and ETB. While the FDA does not require liver enzyme
testing, there have been reported cases of increased hepatic
enzymes. Since Opsumit is a category X drug, women must enroll
in the OPSUMIT REMS program, and they are required to
provide a monthly negative pregnancy test.
Reference: Macitentan. Lexi-Drugs Online [Internet]. Hudson (OH) : Lexi-Comp, Inc. 1978-2013
[cited 2013 Nov 21]. Available from:
http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/4779928.
Approved October 2013
Actelion Pharmaceuticals
4
SCCP
Clinical Pharmacist Spotlight:
Ambulatory Care
Continued from page 1
SCCP: What types of research projects, educational
opportunities, or classes do you typically offer for
students? And at what points should they participate
in your project?
BP: Every year, I offer an elective course known as
³,QWURGXFWLRQWR3RVW-graduate ResiGHQF\7UDLQLQJ´WRDOO
3rd year students who are interested in completing
residency training upon their graduation. Certainly, this
course as well as other courses in our curriculum will help
students discover whether residency training is something
they really want to pursue. In addition, I provide
mentorship for students who want to pursue residency
training beyond the completion of the course. I also work
with many students for their seminar preparation.
SCCP: What are your best pieces of advice for
students who are interested in residency and clinical
pharmacy?
BP: Start to prepare for residency training as early as you
can. Take the residency elective course in third year, work
hard in school, and learn as much as you can. Get
involved in extracurricular activities and clinical
experiences, and importantly, treat each APPE rotation as
a real job interview.
SCCP: As our SCCP faculty advisor, what kinds of
educational opportunities can SCCP provide to its
members?
I believe that SCCP is a great avenue for student
involvement. Students can learn more about clinical
pharmacy, get to know people in our profession, and
expand their networking. Taking advantage of those
learning opportunities offered by SCCP, such as CV
review service and the Clinical Pharmacy Challenge
student competition, students can gain unique experiences
that help them better prepare for residency training.
New Drug Digest:
Prothrombin Complex
Concentrate (Kcentra)
Jennifer Dean,
Pharm.D. Candidate
Kcentra is an IV agent used to reverse acute major bleeding
in patients with an acquired deficiency in clotting factors due
to vitamin K antagonism.
As a prothromin complex
concentrate, it contains vitamin K dependent clotting factors:
Factor II, Factor VII, Factor IX, Factor X, Protein C, and
Protein S. The dosage of Kcentra is determined by the
SDWLHQW¶V EDVHOLQH ,15 DQG ZHLJKW $GYDQWDJHV RI .FHQWUD
include not requiring thawing or blood group typing. It is
coadministered with IV vitamin K. The most serious adverse
reactions to monitor for are stroke, pulmonary embolism, and
deep vein thrombosis.
Reference: Kcentra. Lexi-Drugs Online [ Internet] . Hudson (OH) : Lexi-Comp, Inc. 19782013 [ cited 2013 Nov 21] . Available from: http://online.lexi.com/lco/action/doc
/retrieve/docid/patch_f/1034779.
Approved May 2013
CSL Behring Pharmaceuticals
5